Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction

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Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction

Official Title ICMJE

Efficacy and Safety Study of Using Oral Sildenafil and Intracavernosal Alprostadil Injection as a Combined Pharmacotherapy for Men With Difficult to Treat Erectile Dysfunction.

Brief Summary

Erectile dysfunction (ED or impotence) is a common medical condition affecting many men world wide. The most commonly used treatment for ED are oral medications like Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil). If these are not effective the use of an injection into the penis (intracavernosal injection or ICI) is necessary. However in some men neither of these therapies is successful.

Hypothesis: An adequate erection may be achieved in men with difficult-to-treat erectile dysfunction, when they are treated with a therapy of combination of tablet and penile injection, when a single treatment therapy has failed for these men.

Aim of the study is to test the safety and efficacy of a combination of Viagra and Caverjet Impulse in a group of men who had failed to achieve an adequate response to the maximum recommended dose of either Viagra, Cialis or Levitra and Caverjet Impulse, when these treatments were used alone.

20 men with difficult to treat ED will be given oral medication, intracavernosal therapy or the combination in a single-blind randomised study.

Informed consent will be signed prior to any study procedures being carried out. All participants are 'blinded' to their study treatments. Participants who have satisfactory response to any of the tablets or penile injections, will be excluded from the study.